FDA UDI
In Commercial Distribution
🇺🇸 United States
Comforgel
DI: 08434048106349
·
Model: CG0401
·
PRIM S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Comforgel
- Primary DI
- 08434048106349
- Version / Model
- CG0401
- Catalog Number
- 736448
- Company Name
- PRIM S.A.
- Labeler DUNS
- 462011560
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-08
- Public Version
- 1
- Public Version Date
- 2024-03-18
- Public Version Status
- New
- Public Device Record Key
- 9e471bb4-f503-4431-8943-e1e4b8c16cfb
Device Description
Extra-thin non-slip mini-insoles, Gel
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYS | Insoles, Medical | General Hospital | 880.6280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41575 | Orthotic insole, prefabricated, non-antimicrobial | A prefabricated shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot; it does not include an antimicrobial agent(s). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08434048106349 | GS1 |